End Stage Renal DiseaseNCT05540457
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
A study testing Intermittent Non-InvasiveBlood Pressure Monitor in people with End Stage Renal Disease and End Stage Renal Disease on Dialysis, run by The Rogosin Institute at 1 site in United States.
Trial summary
Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension
- What is being tested?
- Intermittent Non-InvasiveBlood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Participant weighs ≥ 34kg.
- Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.
Who cannot join
- Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
- The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.
- Conditions
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension, Dialysis Induced Hypertension
- Being tested
- Intermittent Non-InvasiveBlood Pressure Monitor
- Keywords
- Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Non-InvasiveBlood Pressure MonitorDevice
Brachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis.
Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Blood Pressure (NIPB)Monitors | Experimental | NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis.
VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis. Receives: Device: Intermittent Non-InvasiveBlood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive Blood Pressure Monitor (NIPB) Measurements
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.
Measured: 7 days from start of participation
Secondary outcomes (2)
Intradialytic Blood Pressure Events
Summary of observed intradialytic BP events (hypertensive andhypotensive)
Measured: 7 days from start of participation
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)
Participant Preference Questionnaire (PPQ)
Measured: 7 days from start of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start22 Sep 2022
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Outset Medical, CareTaker Medical LLC
- Responsible party
- Sponsor
- Investigators
- Frank Liu, MD, Principal investigator, The Rogosin Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540457
- Sponsor's protocol ID
- 2022-01
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT05540457
- Acronym / sponsor ID
- 2022-01
- Conditions
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension, Dialysis Induced Hypertension
- Keywords
- Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Outset Medical, CareTaker Medical LLC
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Blood Pressure (NIPB)Monitors | Experimental | Device: Intermittent Non-InvasiveBlood Pressure MonitorNIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis. VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Participant weighs ≥ 34kg.
- Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.
Key exclusion criteria (2 listed)
- Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
- The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Non-InvasiveBlood Pressure MonitorBrachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis. Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis. | Device | Non-Invasive Blood Pressure (NIPB)Monitors |
Primary outcome
Non-invasive Blood Pressure Monitor (NIPB) Measurements
Time frame: 7 days from start of participation
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.
2 secondary outcomes
Intradialytic Blood Pressure Events
Time frame: 7 days from start of participation
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)
Time frame: 7 days from start of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Liu, MD principal investigator
The Rogosin Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Non-InvasiveBlood Pressure Monitor in people with End Stage Renal Disease and End Stage Renal Disease on Dialysis, run by The Rogosin Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive Blood Pressure Monitor (NIPB) Measurements (time frame: 7 days from start of participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.